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eCTD editor na registraci léčiv
http://www.ectd-editor.com/
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eCTD Editor - home | ectd-editor.com Reviews
https://ectd-editor.com
eCTD editor na registraci léčiv
ectd-editor.com
eCTD Editor
http://www.ectd-editor.com/ectd-editor.aspx
ECTD Editor - Properties. The eCTD Editor enables to create a valid submission for pharmaceutical registration at the Regulatory Office, e.g. SÚKL, in accordance with the ICH M2 EWG specification and to update this submission as the preparation develops and its new variations are created. The application respects current versions of relevant regulations, in particular the following ones:. Electronic Common Technical Document Specification v 3.2.2 (PDF). EU modul 1 v 2.0 (PDF). When creating a submission,...
eCTD Editor - Consultations
http://www.ectd-editor.com/services.aspx
ECTD Editor - services. We offer the following services:. ECTD Editor software support. Preparing documentation before registration. ECTD Editor in the Starter edition does not have to be installed you can start using it through the website. Nevertheless, you may appreciate our assistance services in some situations, e.g. when you have a large number of documents. We will do the task using the software instead of you. ECTD Editor software support. We are ready to provide you consultations. Query: Our ini...
eCTD Editor - home
http://www.ectd-editor.com/language.aspx?culture=cs-CZ&returnUrl=/
Register and Start Using it. Valid submission in accordance with ICH M2 EWG. Anywhere in the EU now possible online at our website. Using eCTD Editor is surprisingly easy. As we had basic documents for the first registration of the preparation already prepared, creating a valid submission in the eCTD format took no more than 2 hours. Moreover, we do not have to worry about how the eCTD format keeps developing. Thanks to software support the program is always up-to-date.". Validation criteria 5.0.
eCTD Editor - home
http://www.ectd-editor.com/default.aspx
Register and Start Using it. Valid submission in accordance with ICH M2 EWG. Anywhere in the EU now possible online at our website. Using eCTD Editor is surprisingly easy. As we had basic documents for the first registration of the preparation already prepared, creating a valid submission in the eCTD format took no more than 2 hours. Moreover, we do not have to worry about how the eCTD format keeps developing. Thanks to software support the program is always up-to-date.". Validation criteria 5.0.
eCTD Editor - Guide
http://www.ectd-editor.com/guide.aspx
ECTD Editor guide through the program. Creating, updating, deleting and finding a preparation. First, you need to create a preparation for which you will be creating documentation a submission . To start, you need to click on this icon:. Enter the product’s name. The program will verify if you have used allowed characters. Press OK. A new product will appear in the product chart just below the toolbar. Click on the image to enlarge. Changing the product’s name. All products will find all products. The se...
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eCTDconsultancy - The Science Of Submissions
2014/01/24 Common Electronic Submissions Gateway (CESG) to send regulatory transactions to Health Canada. 26/02/2014 TGA reaches Electronic-only (eCTD) submissions milestone. REMINDER: EMA gateway made mandatory. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. Join our mailing list. ECTDconsultancy: the Science of Submissions. ECTDconsultancy is software in...
eCTDconsultancy - The Science Of Submissions
2014/01/24 Common Electronic Submissions Gateway (CESG) to send regulatory transactions to Health Canada. 26/02/2014 TGA reaches Electronic-only (eCTD) submissions milestone. REMINDER: EMA gateway made mandatory. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. Join our mailing list. ECTDconsultancy: the Science of Submissions. ECTDconsultancy is software in...
eCTD Editor - home
Register and Start Using it. Valid submission in accordance with ICH M2 EWG. Anywhere in the EU now possible online at our website. Using eCTD Editor is surprisingly easy. As we had basic documents for the first registration of the preparation already prepared, creating a valid submission in the eCTD format took no more than 2 hours. Moreover, we do not have to worry about how the eCTD format keeps developing. Thanks to software support the program is always up-to-date.". Validation criteria 5.0.
eCTD News
Phone: 49 (0)7732.939.1650. Fax: 49 (0)7732.939.1655. Web: www.exalon.com. Tax No. (USt-IdNr): DE 255 908 675. Dr Michael Braun, Sibylle Teuchmann, Michael Zingrebe. The eCTD (electronic Common Technical Document) is currently the only electronic submissions standard for drug regulatory submissions for human medicinal products that is accepted by the European Medicines Agency, the U.S. Food and Drug Administration, Health Canada, and Swissmedic. July 22nd 2015, 15:09. July 1st 2015, 15:13. EMA releases r...
eCTD研究会 公式サイト | Japan eCTD society
PMDA eCTD 提出状況 2017.1.10 Update. 製薬協 ICH日本シンポジウム2016 第35回ICH即時報告会 東京 全電通ホール. 製薬協 FDA/PMDA Validation Rulesの差分分析 -SDTMのCheck Configuration 比較-. PMDA PMDA Gateway よくある質問 を更新しました.
EAAA – Just another WordPress site
Just another WordPress site. February 15, 2018. Welcome to WordPress. This is your first post. Edit or delete it, then start writing! Theme: Clean Biz by eVisionThemes.
eCTD World
Phone: 49 (0)7732.939.1650. Fax: 49 (0)7732.939.1655. Web: www.exalon.com. Tax No. (USt-IdNr): DE 255 908 675. Dr Michael Braun, Sibylle Teuchmann, Michael Zingrebe. The eCTD (electronic Common Technical Document) is currently the only electronic submissions standard for drug regulatory submissions for human medicinal products that is accepted by the European Medicines Agency, the U.S. Food and Drug Administration, Health Canada, and Swissmedic. July 22nd 2015, 15:09. July 1st 2015, 15:13. EMA releases f...
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